CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 400 enrolled
Drug / intervention
ACE Inhibition +2 moredrug
Likely dose
ACE Inhibition 6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00221845
NCT00221845Phase 3Completed

Molecular Mechanisms of Disease Progression and Renoprotective Pharmacotherapy in Children With Chronic Renal Failure

Heidelberg University·interventional·Posted Sep 22, 2005·Updated Jan 12, 2010

In Brief

A Phase 3 clinical trial evaluating ACE Inhibition, Intensified Blood Pressure Control, and 1 other intervention for Children and 4 related conditions. Completed, enrolled 400 participants across 33 sites in 12 countries.

Detailed Summary

In children with chronic kidney disease, progression to end-stage renal failure is associated with high patient morbidity and poor quality of life. In adults, inhibition of the renin angiotensin system (RAS) slows down the rate of renal failure progression. This concept is as yet unproven in children, in whom chronic renal failure (CRF) is more commonly due to hypo/dysplastic malformations than to acquired glomerulopathies as typical for adult chronic kidney disease. The current project aims at assessing the genetic and molecular mechanisms and cardiovascular consequences of progressive CRF and to develop a strategy of pharmacological renoprotection in children.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, France, Germany, Hungary, Italy, Lithuania, Poland, Portugal, Serbia, Sweden, Switzerland, Turkey (Türkiye)

Timeline

Phase 3CompletedFinished
199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJan 1, 1998
Primary CompletionJul 1, 2007
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 20.8 years ago

Interventions

ACE Inhibitiondrug

ACE inhibitor ramipril (6 mg/m²/day) will be given to all subjects.

Intensified Blood Pressure Controldrug

Any antihypertensive drugs except ACE inhibitors and angiotensin receptor blockers will be allowed.

Add-on Angiotensin Receptor Blockadedrug

In patients who show persistent or breakthrough proteinuria at the end of the initial study period, telmisartan (50 mg/m²/day) will be added to the existing medication.